KAI Pharmaceuticals Initiates Third Phase 2a Study In Program To Develop KAI-1678 For The Treatment Of Neuropathic Pain

Main Category: Pain / Anesthetics
Also Included In: Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 14 Apr 2009 - 3:00 PDT

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KAI Pharmaceuticals, Inc., a privately held drug discovery and development company, announced the Company has initiated a third Phase 2a study of KAI-1678, a first-in-class, isozyme-selective, small peptide inhibitor of the epsilon protein kinase C pathway (epsilon PKC). The study has begun enrollment of patients for the treatment of chronic neuropathic pain associated with spinal cord injury (SCI). In December 2008, KAI announced the initiation of its first Phase 2a study of KAI-1678 in patients with moderate-to-severe postoperative pain following total hip or total knee replacement. A second Phase 2a trial in patients with chronic postherpetic neuralgia was initiated last month.

KAI's Phase 2a SCI study is a double-blind, randomized, placebo- and active-comparator-controlled, single-dose, crossover trial designed to evaluate the efficacy of KAI-1678 administered by subcutaneous (SQ) infusion. The primary endpoint of the study, which is being conducted in Australia, is the mean change from baseline in pain intensity scores at the end of drug infusion.

KAI-1678 has been shown to be highly effective at reversing pain in preclinical models of both neuropathic and inflammatory pain, two applications for which epsilon PKC has been well-validated in the peer-reviewed scientific literature. The Company's Phase 1 results indicated KAI-1678, a non-opioid, non-NSAID, was safe and well-tolerated in healthy volunteers.

Gregory Bell, KAI's Senior Vice President of Development and Chief Medical Officer, commented, "There is a substantial need for new approaches that can avoid the side effects of current therapies for both acute and chronic pain. We are pleased by the continued momentum of our 1678 program, which is the first selective inhibitor of epsilon PKC in clinical trials."

Background on Pain

Approximately 50 million people in the United States suffer from some form of persistent pain, while another 25 million suffer acute pain each year as a result of injury or surgery. The prevalence of chronic pain following spinal cord injury is estimated to be between 60 to 80 percent, with 20 to 30 percent of these patients reporting their pain as severe.

Overall, four out of ten people suffering moderate-to-severe pain were unable to find adequate pain relief, according to a survey by the American Pain Society. There is a major need for novel therapeutics with unique mechanisms of action that provide effective pain relief with reduced side effects. Current treatments for pain, such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs), can be limited by serious side effects and inadequate efficacy.

About KAI Pharmaceuticals

KAI is a drug discovery and development company with multiple, novel clinical-stage programs in cardiovascular disease and pain. KAI's lead product candidate, KAI-9803, is currently in a Phase 2b study (PROTECTION AMI) designed to assess the effect of KAI-9803 on reducing myocardial injury in heart attack patients. KAI's second clinical program, KAI-1678, has the potential to address both the inflammatory and neuropathic pain markets and currently is in multiple Phase 2a studies.

KAI's expertise is in the selective modulation of intracellular protein: protein interactions and delivery of peptides into the cell. This approach has broad potential and has been validated clinically. The Company has applied its core expertise to discover highly potent and selective inhibitors and activators for validated protein kinase C (PKC) isozymes. KAI is based in South San Francisco, California, and can be found online at http://www.kaipharma.com.

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KAI Pharmaceuticals

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